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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. ALTEON; ALT HA S CLR STD SZ 8

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EXACTECH, INC. ALTEON; ALT HA S CLR STD SZ 8 Back to Search Results
Model Number 190-30-08
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem Failure of Implant (1924)
Event Date 12/03/2020
Event Type  Injury  
Manufacturer Narrative
Pending evaluation.Concomitant device: novation ehxl natural liner g3 36mm; (cn: 140-36-53, sn: (b)(4)).Alteon ha stem collared standard size 8 (cn: 190-30-08, sn: (b)(4)).Biolox delta femoral head 36mm od, +0mm (cn: 170-36-00, sn: (b)(4)).
 
Event Description
As reported, approximately 11 months postop the initial left tha.This (b)(6) y/o male with a history of osteoarthritis, was revised.The patient received a new xle 40mm lipped liner, a 19x245 monobloc and a 40mm +10 head.Devices not returning.The patient requested the implants.Patient was last known to be in stable condition following the event.
 
Manufacturer Narrative
Section h10: (h3) the evaluation of the of the revision reported was likely the result of an insufficient bond between the implant and the bone which led to aseptic loosening of the femoral stem.However, this cannot be confirmed because the component was not returned for evaluation.(d11) concomitant device: novation ehxl natural liner g3 36mm (cn: 140-36-53, sn: (b)(6).Alteon ha stem collared standard size 8 (cn: 190-30-08, sn: (b)(6).Biolox delta femoral head 36mm od, +0mm (cn: 170-36-00, sn: (b)(6).
 
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Brand Name
ALTEON
Type of Device
ALT HA S CLR STD SZ 8
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66 court
gainesville FL 32653
MDR Report Key11060999
MDR Text Key224059061
Report Number1038671-2020-00663
Device Sequence Number1
Product Code MEH
UDI-Device Identifier10885862321107
UDI-Public10885862321107
Combination Product (y/n)N
PMA/PMN Number
K162732
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup
Report Date 01/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Expiration Date09/04/2023
Device Model Number190-30-08
Device Catalogue Number190-30-08
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/06/2020
Initial Date FDA Received12/22/2020
Supplement Dates Manufacturer Received12/22/2020
Supplement Dates FDA Received01/12/2021
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age72 YR
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